Trial Outcomes & Findings for AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT) (NCT NCT01937195)

Results Overview

The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure

Results posted on

2017-04-20

Participant Flow

Patients were enrolled from April 2013 through June 2014. Patients were admitted to the inpatient units at Evangelical Community Hospital.

Participant milestones

Participant milestones
Measure	AccuCath Intravenous Catheter Device AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Overall Study STARTED	95
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	64 Participants n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure

Population: Inpatients requiring IV therapy.

The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt	85.3 percentage of participants Interval 76.5 to 91.7

SECONDARY outcome

Timeframe: Study exit/at catheter removal expected to be up to 7 days post placement

Population: Inpatient units requiring IV therapy.

Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Percentage of Patients With Complications of Peripheral IV Therapy	17.9 percentage of patients Interval 10.8 to 27.1

SECONDARY outcome

Timeframe: Study exit/at catheter removal expected to be up to 7 days post placement

Population: Inpatients requiring IV therapy.

Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Completion of IV Therapy	78 Participants

SECONDARY outcome

Timeframe: Study exit/at catheter removal expected to be up to 7 days post placement

Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Catheter Dwell Time	58 hours Interval 49.1 to 66.8

SECONDARY outcome

Timeframe: Baseline at catheter insertion in the first 3-15 minutes after procedure

Population: Inpatients requiring IV therapy

Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion	100.0 percentage of participants Interval 96.2 to 100.0

SECONDARY outcome

Timeframe: baseline, and up to catheter removal expected to be no more than 7 days post placement

Population: Inpatients requiring IV therapy.

Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Number of Participants Experiencing Adverse Events Total	17 participants
Number of Participants Experiencing Adverse Events Phlebitis	7 participants
Number of Participants Experiencing Adverse Events Infiltration	6 participants
Number of Participants Experiencing Adverse Events Leaking	3 participants
Number of Participants Experiencing Adverse Events Dislodgement	1 participants

SECONDARY outcome

Timeframe: At catheter removal, which is expected to be up to 7 days post placement

Population: Inpatients requiring IV therapy

Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.

Outcome measures

Outcome measures
Measure	AccuCath Intravenous Catheter Device n=95 Participants AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal	97.9 percentage of participants Interval 92.6 to 99.7

Adverse Events

AccuCath Intravenous Catheter Device

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AccuCath Intravenous Catheter Device n=95 participants at risk AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Vascular disorders Vascular Complication	17.9% 17/95 • Number of events 17 • During enrollment from April 2013 through June 2014. IV complications are anticipated events during conventional IV therapy and occur about 47% of the time.

Additional Information

Norman R. Anderson

Evangelical Community Hospital

Phone: 570-222-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place